Case Studies

BSI Medical Devices Brexit Update January 2018

Enews – 31st January 2018

Following the triggering of Article 50, BSI will continue to help organizations achieve their goals as we have done for over a century. For BSI it is business as usual, BSI expects to remain a full member and influential participant in the single European Standards system as well as an EU Notified Body. BSI will continue to play an important role in helping both British and overseas Manufacturers demonstrate product conformity.

BSI has been working closely with UK government departments – such as the Department for Business, Energy & Industrial Strategy, Department for Exiting the EU and UK Department of Health - and the Medicines & Healthcare products Regulatory Authority to ensure they understand the implications not only for UK Notified Bodies but more importantly our clients and patients who use these products.

Current negotiation status

The European Commission published a notice on 11 January 2018 regarding the future recognition of UK Notified Bodies in the EU. This article outlines the worst-case where no withdrawal agreement is achieved. BSI anticipates this situation will be averted with a mutual recognition agreement for UK Notified Bodies. Currently there are recognized existing mechanisms in place for non-EU countries to participate as EU Notified Bodies. For example, the designated organizations in Norway (under EEA recognition), Switzerland and Australia (through Mutual Recognition Agreements) are recognized as Notified Bodies for the purposes of the relevant EU legislation.

On 26 January 2018, the government published an open letter to UK business leaders on the Implementation Period. It emphasises the following three key aspects:

“First, in order that our terms of trade remain unchanged during the implementation period, it will need to be based on the existing structure of EU rules and regulations.”

“Second, no business need worry that it will fall outside the scope of this period. Our intention is to mimic the breadth of our current arrangements, from goods to agriculture to financial services, meaning that every business, small or large, will be able to go on trading with the EU as it does today until it’s time to make any changes necessary for the future partnership.”

“Third, EU citizens will continue to be able to come and live and work in the UK, with no new barriers to taking up employment.”

BSI strengthening European links

Our intention is to further develop and secure BSI’s EU Notified Body activity in mainland Europe and continue building to establish a significant presence in the Netherlands over the next two years. This presence will focus upon the existing BSI Netherlands headquarters in Amsterdam.

Product Certification: BSI has formally applied for designation as a Medical device Notified Body in the Netherlands under the EU Directives; (90/385/EEC) Active implantable medical devices, (93/42/EEC Medical devices) and (98/79/EC) IVD directive within the oversight of the Dutch Health and Youth Care Inspectorate (IGJ). IGJ have completed our initial Audit and we are working through the process of designation.

ISO 13485: BSI has applied for Accreditation under the Dutch Accreditation Council (RVA) and we have received our initial assessments. The RVA accredits management system certification bodies based on the ISO/IEC 17021 standard.

Ongoing Communications

As Brexit negotiations progress and our discussions with the UK government and other relevant authorities evolve, we will continue to keep you informed on progress on both this page and via other communications. For now, we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.

BSI has created a Brexit homepage for you to find all the latest information.